1. Field of the Invention
The present invention relates to a packaged article, and more particularly, concerns a package assembly for an article which is sterilized after being packaged.
2. Background Description
It is common and acceptable practice to pre-package medical articles prior to sterilization. Many medical products such as needles, syringes, catheters, cannulae and other devices normally intended for use in or on the body, or for use in a sterile environment, are required to be sterilized. If any of the aforementioned devices or products are intended for multiple uses, sterilization is usually performed by autoclaving techniques. However, many of these products are intended for one-time use and are disposable thereafter. These disposable, sterile products are tyically packaged by the manufacturer, and then the packaged articles or products are then sterilized in bulk. The articles inside the packages are maintained in a sterile condition by virtue of the properties or arrangement of the packaging material. Thus, when the user, such as a nurse, physician, hospital attendant or the like, is ready to make use of the article, the package is normally opened immediately before use of the article contained within.
Since many disposable, sterile articles are packaged individually, there are at least two major considerations, in addition to the ability to permit and maintain sterilization, which should be taken into account with respect to the design of the packaging. The first factor relates to convenience for the user. In this regard, the package, while sealed to maintain sterility, should be simple, straightforward and easy to open, while not disturbing the sterilized article contained inside the package. The second factor relates to manufacturing operations and cost. Clearly since disposable medical articles are frequently packaged individually, the cost of the materials and labor for the packaging could become quite significant. Therefore, inexpensive materials, as well as simple, direct techniques for sealing the article inside the package, while not compromising on the quality of the packaged article, are the goals of the manufacturers of these packaged articles.
Sterile, disposable medical products are oftentimes included in a blister package, usually in the form of a rigid tray and removable cover or lid sealed over the tray. The disposable article itself is usually pre-packaged in the tray, and after the lid is sealed onto the tray, the packaged assembly, along with similar packaged assemblies, are sterilized in bulk. The most common technique for sterilization of these disposable medical articles is by ethylene oxide (ETO). While blister packages are quite common, effective to use and open, and are manufactured with cost constraints in mind, some problems, nevertheless, exist. Due to ETO sterilization, the package must be "breathable," i.e., allow ETO gas into package without allowing microorganisms to enter. Also ETO gas should be vented out of the package to keep residuals at acceptable levels. Blister package components may be sealed by a number of different techniques including radio frequency (RF) sealing, staking or the use of snaps. However, these sealing techniques have been known to restrict the movement of the blister package components, and cause warpage of the blister trays during the ETO sterilization procedures. In addition, the package contents are frequently disrupted or displaced upon opening due to uneven seal strength of the blister package components. Snaps are difficult to form in a reliable fashion, and often perform in an inconsistent manner.
Other techniques are known for holding blister trays or components together. For example, a catheter set sold as the MINI-BALLOON.TM. catheter system by Becton, Dickinson and Company, Franklin Lakes, N.J. employs a polyethylene tube to hold the upper and lower packaging trays together. However, the package trays, together with polyethylene securing tube, are then inserted in a large blister tub which is sealed with a peelable cover for sterilization purposes. It is appreciated that the multiple packaging components not only adds expense and considerable bulk to the packaged product, but requires additional time and manipulation for gaining access to the sterilized product.
Accordingly, improvements are still being sought in packaged assemblies suitable for medical articles which are to be sterilized and maintained in a sterilized condition until use. The present invention is directed to such an improvement which takes into account the two major considerations or goals set forth above for such packaged articles.